Enteral diet and method for providing nutrition to a diabetic

ABSTRACT

A composition and method for providing nutrition, or a nutritional supplement, to a diabetic patient. Pursuant to the present invention, a low carbohydrate, high fat enteral formulation is provided. The fat comprises, in part, medium chain triglycerides (MCTs). Preferably, the composition includes a high percent of mono-unsaturated fats, high amylose starch, and soluble dietary fiber.

This is a continuation-in-part of U.S. patent application Ser. No.08/051,632, filed Apr. 22, 1993, and entitled: "ENTERAL DIET AND METHODFOR PROVIDING NUTRITION TO A DIABETIC."

BACKGROUND OF THE INVENTION

The present invention relates generally to compositions and methods oftreating diabetes. More specifically, the present invention relates to amethod for providing nutrition, or a nutritional supplement, to apatient having diabetes without substantially increasing blood glucoselevels.

Diabetes Mellitus is a chronic disorder affecting carbohydrate, fat, andprotein metabolism. It is characterized by hyperglycemia and glycosuriaresulting from a defect or deficient insulin secretory response. Thenumber of patients diagnosed as diabetic was estimated in 1985 to be 10million in the United States alone, with the figure increasing at a rateof 6% per year. Two major variants of the disease exist.

One variant, seen in about 10% of all idiopathic diabetics is referredto as insulin dependent diabetes mellitus (IDDM) or juvenile onsetdiabetes. This variant is frequently manifested for the first time inyouth and is characterized by progressive loss of insulin secretoryfunction by beta cells of the pancreas and hence a progressive"dependency" on exogenous insulin for the maintenance of carbohydratemetabolism. (This characteristic is shared by those non-idiopathic, or"secondary" diabetics whose disorder have their origins in pancreaticdisease.)

The second variant of idiopathic diabetes is referred to as non-insulindependent diabetes mellitus (NIDDM) or adult onset diabetes mellitus.This variant accounts for the remainder of the idiopathic diabeticpopulation.

All diabetics, regardless of their genetic and environmental backgroundsor age of onset of the disease, have in common an apparent lack ofinsulin or inadequate insulin function. Because transfer of glucose fromthe blood to the muscle and fat is insulin dependent, diabetics lack theability to utilize glucose adequately. Further, because glycogenolysisis ordinarily inhibited by insulin, the rate of glycogenolysis iselevated in diabetics. Both of these "derangements" from normalmetabolic events lead to the accumulation of glucose in the blood(hyperglycemia) to the point where renal glucose reabsorption capacityis exceeded and glycosuria occurs. A major source of energy for thediabetic becomes fatty acids derived from triglycerides stored in fattytissue.

In the liver, fatty acids are oxidized to ketone bodies which arecirculated and used as an energy source by the tissues. In the IDDMpatient and sometimes the NIDDM patient, the rate of formation of theketone bodies may exceed their rate of utilization and ketosis alongwith metabolic acidosis may occur.

Since tissues appear to be starving for glucose, dietary tissue sourcesof protein are used in glycogenesis. Anabolic processes such assynthesis of glycogen, triglycerides and proteins are "sacrificed" tocatabolic activities including glycogenolysis, gluconeogenesis andmobilization of fats. Thus, the diabetic state which has its origins ina "simple" insulin defect, results in widespread metabolic disturbanceshaving long term pathological effects on nearly all organs and tissuesof the body. Indeed, the diabetic state is one of the prime contributorsto deaths caused by myocardial infarction, renal failure,cerebrovascular disease, atherosclerotic heart disease, and systemicinfections.

The hyperglycemic and glycosuric conditions of the diabetic disease maybe treated by a manipulation of the diet, control of body weight, andregulation of physical activity. In some diabetics, particularly thosesuffering from NIDDM, the hyperglycemic and glycosuric conditions can betreated by oral administration of antihyperglycemic agents such asderivatives of sulfonylureas, sulfonamides, biguanides and othercompounds. For diabetics suffering from IDDM and advanced NIDDM,however, therapy has focussed on administration of exogenous insulin.

Of course, the nutritional management of diabetes is of great concern.The American Diabetes Association has published guidelines fornutritional management of diabetes mellitus. These guidelines suggestthat sufficient calories be given to a patient to achieve and maintainreasonable weight.

Pursuant to the ADA (1986 Guidelines), the diet may include up to55%-60%, based on calories, as carbohydrates. The protein content of thediet recommended for people with diabetes in approximately 12%-20% ofthe total calories. The fat content of the diet is recommended to beless than 30% of the total calories. Of this polyunsaturated fats arerecommended up to 10%, saturated fats recommended at less than 10%, andmono-unsaturated fats will make up the remaining percentage of the fatat a range of 10%-15%.

ADA guidelines 1994 revision are more flexible regarding percentage ofcalories from carbohydrates, but emphasize even further the need for anadequate lipid intake.

In many situations, it may be necessary to support a diabetic patientwith an enteral diet or supplement. These diets can either beadministered through a nasogastric tube or other external means orprovided in a liquid form that the patient drinks. Such formulations maybe necessary when patients are hospitalized and/or in other situationswhere the patients are unable to meet necessary dietary requirementswithout a nutritional formulation or supplementation.

Presently, a formulation on the market for a diabetic patient isGlucerna® sold by Ross Product Division, Abbott Labs. See U.S. Pat. No.4,921,877. Glucerna® provides approximately the following macronutrientprofile: protein 16.7% of the calories; carbohydrate 33.3% of thecalories; fat approximately 50% of the calories. The fat in Glucerna® isprovided solely through long-chain triglycerides. Specifically, the fatis provided as 85% of the calories being safflower oil and 15% of thecalories being soybean oil. The caloric density of Glucerna® isapproximately 1 cal/ml.

The inventors of the present invention do not believe that presentlyavailable formulations satisfactorily meet the nutritional needs of thediabetic patient.

SUMMARY OF THE INVENTION

The present invention provides a composition and method for providingnutrition, or a nutritional supplement, to a diabetic patient. Pursuantto the present invention, a moderate to low carbohydrate, high fatenteral formulation is provided. The fat comprises, in part, mediumchain triglycerides (MCTs) and has an n-6:n-3 ratio of preferably notmore than 10.

The present invention allows reduced insulin to metabolize the "meal"and reduces the sensitivity to dose and timing of insulin to blunt thepost-prandial serum glucose excursion. Additionally, due to the contentof the formulation, improvement in the patient's tolerance to theformula is achieved.

To this end, the present invention provides a method for providingnutrition to a diabetic patient without substantially increasing bloodglucose levels comprising the steps of enterally administering acomposition comprising a protein source, a carbohydrate source, and afat source that includes medium chain triglycerides and has an n-6:n-3ratio of not more than 10.

In an embodiment, the composition includes approximately 8 to about 25%of the calories as the protein source.

In an embodiment, the composition includes less than 50% of the caloriesas the carbohydrate source.

In an embodiment, the composition includes approximately 30 to about 50%of the calories as the fat source. In an embodiment, preferably, the fatsource includes long chain triglycerides (LCTs) and the ratio of MCTs toLCTs is approximately 1:4.

In an embodiment, the composition includes dietary fiber.

In an embodiment, the composition includes high amylose starch.

In an embodiment, the fat source of the composition comprisesapproximately 40% to about 70%, by calories, mono-unsaturated fattyacids.

In an embodiment, the composition includes at least one component chosenfrom the group consisting of sucrose, fructose, maltose, sorbitol, orxylitol.

In an embodiment, the composition is administered to the diabeticpatient through a nasogastric tube.

In an embodiment, the composition is administered as a supplementationor a sole source of nutrition to the diabetic patient.

In an embodiment, the diabetic patient is non-insulin dependent.

In an embodiment, the diabetic patient is insulin dependent.

In an embodiment, the fat source comprises, by calories, at least 4%essential fatty acids.

In an embodiment, the composition provides at least 100% of the U.S. RDAof all vitamins and minerals per 1500 Kcal.

An advantage of the present invention is it provides an improvedcomposition for providing nutritional requirements and/or support to apatient having diabetes.

Furthermore, an advantage of the present invention is that it provides amethod for providing nutrition to a patient having diabetes.

Additionally, an advantage of the present invention is that it providesa method and composition for providing nutrition to a diabetic patientwithout substantially increasing blood glucose levels.

Still further, an advantage of the present invention is that it providesa composition specifically directed to the meet the nutritionalrequirements and needs of the diabetic patient.

A further advantage of the present invention is to provide a compositionthat includes, in an embodiment, high amylose starch that is digested ata slower rate than other starches and thereby leads to a reduction inthe rate at which glucose enters the blood stream.

Additionally, an advantage of the present invention is that the use ofhigh amylose starch enhances glycemic control in the diabetic patient.

Moreover, an advantage of the present invention is to provide a fatcourse having an n-6:n-3 ratio that improves immune response.

Furthermore, an advantage of the present invention is to provide aformulation having dietary fiber that will tend to slow down themetabolism of carbohydrates in the formula.

Additional features and advantages of the present invention aredescribed in, and will be apparent from, the detailed description of thepresently preferred embodiments.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

The present invention provides a composition and method for meeting thenutritional requirements of a diabetic patient. Pursuant to the presentinvention, a composition is enterally administered to the patient. Thecomposition of the present invention is a moderate to low carbohydrate,high fat enteral formulation including a protein source, a carbohydratesource, and a fat source having an MCT content. By reducing thecarbohydrate intake and substituting therefor MCTs, the compositionreduces the insulin necessary to metabolize the meal. Additionally, thecomposition reduces sensitivity to dose and timing of insulin to reducethe post-prandial serum glucose excursion. The present inventionprovides benefits in improved tolerance, metabolic and glucosemanagement/insulin requirements and additional advantages.

An advantage of the present invention is provided by non-glucose,non-insulin dependent alternatives to carbohydrates in an enteralproduct for diabetes. The present invention avoids disadvantages of manycurrent products and minimizes the increase in blood glucose and theassociated insulin requirement which follows feeding of these patients.

In an embodiment, another advantage of the present invention is that itprovides a formula including dietary fiber that will slow down themetabolism of the carbohydrates in the formula. Additionally, the use ofa high amylose starch in the formula will lead to a reduction in therate at which glucose enters the blood stream. Because it is resistantto digestion by pancreatic enzymes, the high amylose starch of thecomposition of the present invention enhances glycemic control in thediabetic patient. An advantage of the formula of the present inventionis that it provides a composition having a low carbohydrate content andhigh amylose starch that is slowly digested.

The fat source preferably comprises approximately 30% to about 50% ofthe total calories of the composition. In a preferred embodiment, 30% toabout 44% of the calories are derived from the fat source. The fatsource comprises long chain triglycerides (LCTs) and medium chaintriglycerides (MCTs).

MCTs can be a mixture of C6-C12. For example, MCTs can be a mixture ofC6:0(1-2%), C8:0(65-75%), C10:0(25-30%), and C12:0(1-2%). In anembodiment, the MCTs comprise 20% of the fat source and LCTs comprise80% of the fat source.

The use of MCTs aids in digestion. Digestion of MCTs may be easier thanLCTs in that LCTs are digested by various lipases; in contrast to LCTs,pancreatic lipase is not essential to digestion of MCTs. Additionally,absorption of MCTs is faster as compared to LCTs. LCTs requireincorporation into chylomicron by intestinal mucosal cells. Similarly,transport of MCTs is via portal circulation directly to the liverwhereas LCTs are transported via lymphatics and systemic circulationbefore finally ending up in the liver. LCTs are oxidized more slowlyrequiring carnitine for entry into the mitochondria. The source of MCTscan comprise fractionated coconut oil.

Preferably, the LCTs are provided as canola oil, olive oil, and hi-oleicsafflower oil. Although other oils can be used such as, e.g., soy oil,high-oleic sunflower oil, or any oil rich in mono-unsaturated fatty acid(MUFA). These oils not only provide linoleic acid, an essential fattyacid, but also provide n-3 fatty acids. Linolenic acid, the predominaten-3 fatty acids supplied by these oils, may serve as a precursor toother n-3 fatty acids which have anti-inflammatory activity. Preferably,at least 4%-10%, by calories, essential fatty acids are provided by thecomposition of the present invention.

Preferably, in an embodiment, the ratio of n-6:n-3 fatty acids isapproximately 4. However, other ratios can be used with preferably theratio of n-6:n-3 being 2 to 10. This lower ratio improves the immuneresponse.

Additionally, the fat source comprises approximately 40% to about 70% ofthe total calories as mono-unsaturated fatty acids (MUFA). In apreferred embodiment, the MUFA content of the fat is approximately 58%by caloric content. This higher level of MUFA as part of a highfat/moderate carbohydrate diet provides lower serum lipids than a lowerfat diet that does not contain a significant amount of MUFA. Anadvantage of the composition of the present invention is that itprovides a high fat diet with MCTs and a high content of MUFAs.

Pursuant to the present invention, preferably the composition provides 8to about 25% of the total calories as a protein. Preferably, theformulation contains caseinate, whey protein, or non-fat milk as theprotein source.

Preferably the composition comprises approximately 30 to less than 50%in total calories as a carbohydrate and most preferably approximately40% as a carbohydrate. A variety of carbohydrates can be utilized suchas maltodextrins or other complex polysaccharides. If desired, thecarbohydrates can be substituted for, in part, by fructose, sucrose,maltose, sorbitol or xylitol. This will provide non-glucose, non-insulindependent alternatives which provide carbon skeletons to be used as anenergy source.

Preferably, the carbohydrate component will comprise in part starch.Preferably, the composition will include a high amylose starch. A highamylose starch provides advantages over, for example, an acid modifiedstarch. A high amylose starch will break down much more slowly than anacid modified starch and is digested more slowly as well. This leads toa reduction in the rate at which glucose enters the blood stream.

In a preferred embodiment, the high amylose starch will consist ofapproximately 25 to about 75% amylose and approximately 25% to about 75%amylopectin. In a most preferred embodiment, the amylose starch willconsist of approximately 70% amylose and approximately 30% amylopectin.

In a preferred embodiment, the high amylose starch will compriseapproximately 1% to about 5% of the composition; approximately 10 to 50g/L of the composition. In a most preferred embodiment, the high amylosestarch will comprise approximately 2.1% (23 g/L) of the composition.

Additionally, the composition, in a preferred embodiment, will includedietary fiber. The addition of dietary fiber to the formula tends toslow down the metabolism of the carbohydrates in the formula.Preferably, the composition includes approximately 8 grams to about 25grams per liter of the composition as dietary fiber.

The dietary fiber will preferably include both soluble and insolublefiber. Preferably, the soluble fiber will comprise approximately 50 toabout 75% of the fiber present. In a most preferred embodiment, thesoluble fiber will comprise approximately 70% and the insoluble fiberwill comprise 30% of the total fiber content.

Preferably, the formulation will provide 100% of the U.S. RDA in 1500kcal of all vitamins and minerals. Additionally, preferably, the presentinvention provides 1.0-1.5 kcal/ml.

The composition can include a surfactant. A variety of surfactants canbe used such as egg yolk phospholipids, soy phospholipids, and milkphospholipids.

By way of example and not limitation, an example of the presentinvention will now be given. The formulation is intended for a diabeticpatient. The formulation can be fed by mouth or by tube or can be usedas a supplement or as a complete diet.

EXAMPLE

    ______________________________________                                                                          US Diabetic                                 Nutrient  Source         Unit     (Per Liter)                                 ______________________________________                                        Caloric Density          Kcal/ml  1.0                                         Protein   (18% Cal)      g        45                                                    Caseinates     g        45                                          Fat       (42% Cal)      g        50                                                    MCT            g        10                                                    Canola oil     g        18.5                                                  Hi-Oleic Safflower                                                                           g        18.0                                                  Soy Lecithin   g        3.5                                                   n-6:n-3 ratio           3.5                                                   MCT/LCT = 20/80                                                     CHO       (40% Cal)      g        100                                                   Maltodextrin   g        45                                                    High amylose starch                                                                          g        23                                                    Fructose       g        22                                                    Pectin         g        3                                                     Soy fiber      g        5                                                     Gum Arabic or guar                                                                           g        7                                           Dietary Fiber            g        15                                          Flavoring                         Vanilla                                     Lactose                           Lactose free                                Vitamin A                IU       4000                                        Beta-carotene            mg       2                                           Vitamin D                IU       320                                         Vitamin E                IU       30                                          Vitamin K                mcg      50                                          Vitamin C                mg       140                                         Folic Acid               mcg      400                                         Thiamine                 mg       2                                           Riboflavin               mg       2.4                                         Vitamin B6               mg       4                                           Vitamin B12              mcg      8                                           Niacin                   mg       28                                          Biotin                   mcg      300                                         Pantothenate             mg       14                                          Choline                  mg       400                                         Calcium                  mg       720                                         Phosphorus               mg       720                                         Magnesium                mg       286                                         Iodine                   mcg      120                                         Manganese                mg       3                                           Copper                   mg       1.5                                         Zinc                     mg       15                                          Iron                     mg       12.8                                        Sodium                   mg       740                                         Potassium                mg       1400                                        Chloride                 mg       1200                                        Selenium                 mcg      75                                          Chromium                 mcg      125                                         Molybdenum               mcg      200                                         Carnitine                mg       100                                         Taurine                  mg       100                                         M-Inositol               mg       800                                                   Comments                                                            Osmolality:                                                                             425 mOsm/kg water                                                             max.                                                                Viscosity:                                                                              90 CPS max.                                                         Packaging:                                                                              cans or bags                                                        Processing:                                                                             UHT aseptic or                                                                Retorting                                                           ______________________________________                                    

By way of comparison, a comparison of the diabetic formula of thepresent invention vis-a-vis Glucerna® from Ross is set forth below.

    __________________________________________________________________________                    Present                                                                            Ross                                                                     Invention                                                                          Glucerna ®                                                                       Comments                                          __________________________________________________________________________    Caloric    Kcal/mL                                                                            1    1.06                                                     Density:                                                                      Caloric                     ADA Guideline                                                                           ADA Guideline                           Distribution:               (1986)    (1994)                                  Protein    %    18   16.7   12-20     10-20                                   Fat        %    42   50     <30       <10% saturated                                                      (<10% saturated)                                  CHO        %    40   33.3   55-65                                             Protein                                                                       Composition:                                                                             g/L  45   41.8   100% Casein                                                                             100% Casein                             Total Protein                                                                 Fat                                                                           Composition:                                                                  Total Fat  g/L  50   55.7                                                     MCT        g/L  10   0      MCT/LCT = 20/80                                                                         No MCT                                                              Canola    Soy                                     LCT        g/L  40   55.7   hi-oleic safflower                                                                      hi-oleic sallower                       Fatty Acids                                                                   Profile:                                                                      MCT        %    18   0      7.6% of TEI                                                                             0% of TEI                               LCT                                                                           Saturated  %    7.6  11.2   3.3% of TEI                                                                             5.6% of TEI                             Mono-      %    57.8 76.1   58%       76%                                     Unsaturated                 of fat calories                                                                         of fat calories                         Poly-      %    17.1 12.7                                                     Unsaturated                                                                   n6:n3 Ratio     3.5  14                                                       EFA        %    7.2  7.1    EFA:7.2% of TEI                                                                         EFA:7.1% of TEI                         Carbohydrate                                                                  Composition:                                                                  Total CHO's                                                                              g/L  105  93.7             Total includes                          Total avail-                          all fibers                              able CHO' s                                                                              g/L  100  83.3                                                     High amylose                                                                             g/L  23   0      Resistant Contains                                Starch                      to digestion                                                                            no starch                               Maltodextrin                                                                             g/L  45   44.4                                                     Fructose   g/L  22   17.7                                                     Soluble fibers                                                                           g/L  10   0.75                                                     Insoluble  g/L  5    13.65                                                    fibers                                                                        Lactose                     Lactose-free                                                                            Lactose-free                            Dietary Fiber                                                                 Composition:                                                                  Total D.   g/L  15   14.4   Soluble:  95% insoluble                           Fibers                      Insoluble = 2:1                                   Pectin     g/L  3    --     Note: soluble fiber                               Gum Arabic g/L  7    --     slows ↓ digestion                          Soy fiber  g/L  5    14.4                                                     Vitamins: Meet 100%                                                                           1400 1422                                                     USRDA's in Kcals:                                                             Minerals: Meet 100%                                                                           1400 1422                                                     USRDA's in Kcals:                                                             Trace Nutrients include Cr, Mo, Se, Taurine, Carnitine, m-inositol            Chromium:  mcg/L                                                                              125  124    "Cr" improves                                                                 glucose tolerance                                 Flavoring       Vanilla                                                                            Vanilla                                                  Taste           Sl. sweet                                                                          Sl. sweet                                                Osmolality      400  375                                                      __________________________________________________________________________

By way of example, and not limitation, a contemplative example of theuse of the formulation will now be given.

CONTEMPLATIVE EXAMPLE

A 45 year old insulin dependent diabetic female patient is admitted tothe Intensive Care Unit with severe head trauma and multiple otherinjuries following an auto accident. She is unconscious and will requiretube feeding of an enteral formula to meet her basic and stressnutritional needs. Standard enteral tube feeding formulas with onlymaltodextrin will produce high levels of blood glucose, increase insulinrequirements, and make her diabetes hard to control during her recoveryfrom the accident. Standard formulas with only long chain triglyceridesare less well tolerated, absorbed less well, and metabolized moreslowly.

Instead of a standard enteral tube feeding formula, she is administeredby tube the formula of the present invention. The formula isadministered until the patient can satisfy her caloric requirementsthrough a normal diet.

The high amylose starch and medium chain triglycerides of this inventionserve to blunt the increase of blood sugar and make her diabetes easierto control. In addition, the MCTs are more easily and rapidly absorbed,and are better transported, metabolized, and utilized as an energysource with better gastrointestinal tolerance, all of which are of asignificant benefit to this type of patient.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present invention andwithout diminishing its attendant advantages. It is therefore intendedthat such changes and modifications be covered by the appended claims.

We claim:
 1. A method for providing nutrition to a diabetic patientwithout substantially increasing blood glucose levels comprising thesteps of enterally administering to the diabetic patient a lowcarbohydrate, high fat enteral composition comprising:a protein source;a carbohydrate source including a slowly digested high amylose starchcomponent; and a fat source that includes medium chain triglycerides andhas an n-6:n-3 ratio of not more than
 10. 2. The method of claim 1wherein approximately 8 to about 25% of the calories of the compositionare provided as the protein source.
 3. The method of claim 1 whereinless than 50% of the calories of the composition are provided as thecarbohydrate source.
 4. The method of claim 1 wherein approximately 30to about 44% of the calories of the composition are provided as the fatsource.
 5. The method of claim 1 wherein the composition includes fromabout 1% to about 5% of high amylose starch based on the overallcomposition.
 6. The method of claim 5 wherein the high amylose starchincludes approximately 25 to about 75% amylose and approximately 25% toabout 75% amylopectin.
 7. The method of claim 1 wherein the fat sourcecomprises approximately 40 to 70% mono-unsaturated fats.
 8. The methodof claim 1 wherein the composition further comprising dietary fiber. 9.The method of claim 8 wherein the dietary fiber includes both solubleand insoluble dietary fiber.
 10. A method for providing nutrition to adiabetic patient comprising the steps of enterally administering to thediabetic patient a composition that comprises:a protein source thatprovides at least about 8% of the total calories of the composition; acarbohydrate source that provides less than about 50% of the totalcalories of the composition, the carbohydrate source including a slowlydigested high amylose starch; and a fat source that provides at least30% of the total calories of the composition, including medium chaintriglycerides (MCTs) and having an n-6:n-3 ratio of 10 or less.
 11. Themethod of claim 10 wherein the fat source includes at least one oilselected from the group consisting of olive oil, canola oil, hi-oleicsafflower oil, and hi-oleic sunflower oil.
 12. The method of claim 10wherein the composition is administered to the diabetic patient througha nasogastric tube.
 13. The method of claim 10 wherein the compositionis administered as a supplementation to the diabetic patient.
 14. Themethod of claim 10 wherein the diabetic patient is non-insulindependent.
 15. The method of claim 10 wherein the fat source includeslong chain triglycerides (LCTs) and the ratio of MCTs to LCTs beingapproximately 1:4.
 16. The method of claim 10 wherein the fat sourcecomprises approximately 30% to 70%, by calories, mono-unsaturated fattyacids.
 17. The method of claim 10 wherein the high amylose starchcomprises from about 1% to about 5% of the overall composition.
 18. Themethod of claim 10 wherein the composition provides dietary fiber. 19.The method of claim 18 wherein the dietary fiber includes both solubleand insoluble dietary fiber.
 20. A method for providing nutrition to apatient with diabetes without increasing blood glucose levelscomprising:enterally administering to the patient with diabetes aneffective amount of a composition comprising a protein source, acarbohydrate source that includes high amylose starch, a fat sourceincluding a mixture of medium and long chain triglycerides wherein thefat source comprises approximately 30% to 70%, by calories,mono-unsaturated fatty acids, and dietary fiber.